BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy recalls Iohexol (300 mg Iodine/mL), 2.4 g Iodine/8 ml, Total Volume 8 ml in 10 ml syringe, 5-count syringes packaged in a bag la
Recalled December 21, 2022 · FDA recall D-0086-2023 · BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy
Hazard
Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL · FDA Class I
Units
250 syringes
Sold at
BayCare Health System hospitals in FL
Description
Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL
Product
Iohexol (300 mg Iodine/mL), 2.4 g Iodine/8 ml, Total Volume 8 ml in 10 ml syringe, 5-count syringes packaged in a bag labeled as Omnipaque (iohexol) 300 mg I/mL, 2.4g Iodine/8 mL in a 10 mL syringe, Compounded with GE Healthcare product, Each mL contains (647 mg) of iohexol as 300 mg of organically bound iodine, 1.21 mg tromethamine, and 0.1 mg edetate calcium disodium, For Injection or oral use; Rx Only, BayCare Central Pharmacy, 7802 Telecom Parkway, Temple Terrace, FL 33637.
Manufacturer(s)
BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →